Trinity Care Solutions Recalls Pfizerpen Due to Sterility Concerns
Trinity Care Solutions is recalling 7 units of Pfizerpen (penicillin G) compounded in Florida due to quality control concerns regarding sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in a parenteral (injectable) drug, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 7 units of Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS. The affected product was compounded by the pharmacy in Ocala, Florida, and is identified by Rx # 29183 with a discard date of 05/21/14.
The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Specifically, there is a lack of assurance of sterility for the sterile products compounded by the pharmacy within their expiry dates. The FDA has classified this recall as Class II.
Consumers and healthcare providers who have this specific product should stop using it and contact their pharmacist or the recalling firm for further instructions. This recall affects all lots of sterile products compounded by the pharmacy within the expiry period.
The recalled product
- Product
- Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Rx 29183 Exp
- 5/21/2014
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 30 recalled by Franck's Lab Inc dba Trinity Care Solutions under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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